{"active_ingredient":["Active Ingredient Phenylephrine HCI 0.25%","Active Ingredient Mineral Oil 14%","Active Ingredient Petrolatum 74.9%"],"dosage_and_administration":["Directions Children under 12 years of age; ask doctor before use Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying. When first opening tube, remove foil seal Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use. Regular use provides continual therapy for relief of symptoms also apply ointment to external area."],"effective_time":"20241217","id":"297d6588-c5d2-b441-e063-6394a90a8a64","inactive_ingredient":["Inactive Ingredients Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol"],"indications_and_usage":["Uses Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful"],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M015"],"brand_name":["Hemorrhoidal"],"generic_name":["MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI"],"is_original_packager":[true],"manufacturer_name":["Rugby"],"package_ndc":["0536-1288-06"],"product_ndc":["0536-1288"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1372298"],"spl_id":["297d6588-c5d2-b441-e063-6394a90a8a64"],"spl_set_id":["a5b5e0a9-eee9-2a1e-e053-2a95a90a464e"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","MINERAL OIL","PETROLATUM"],"unii":["04JA59TNSJ","T5L8T28FGP","4T6H12BN9U"]},"package_label_principal_display_panel":["Packaging Hemorrhoidal ointment"],"pregnancy_or_breast_feeding":["If Pregnant or breast-feeding Ask a doctor before use"],"purpose":["Purpose Vasoconstrictor","Purpose Protectant","Purpose Protectant"],"questions":["Questions or Comments? 1-800-645-2158"],"set_id":"a5b5e0a9-eee9-2a1e-e053-2a95a90a464e","spl_product_data_elements":["Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine HCI STEARYL ALCOHOL BENZOIC ACID CETYL ALCOHOL LAURETH-23 METHYLPARABEN YELLOW WAX GLYCERIN PROPYLPARABEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM"],"spl_unclassified_section":["Drug Facts","Distributed by: Distributed by RUGBY® LABORATORIES 17177 N. Laurel Park Drive, Suite 233 Livonia, MI. 48152 www.rugbylaboratories.com Made in China This Product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Hemorrhoidal Ointment."],"stop_use":["Stop Use and Ask Doctor if Bleeding occurs Condition worsens or does not improve within 7 days Introduction of applicator into the rectum causes additional pain"],"storage_and_handling":["Other Information Store at room temperature 20º-25ºC (68º-77ºF)"],"version":"4","warnings":["Warnings For external and/or intrarectal use only Ask doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask doctor before use if you are presently taking a prescription drug for high blood pressure or depression."]}